Head of Clinical and Regulatory - St Ives, Cambs or Culham, Oxon

Sector: In vitro Diagnostics
Start: Immediate
Salary: Competitive, depends on experience - +pension +bonus +share options

Company
Sense is a start-up in vitro diagnostics company based in Cambridge and Oxford UK. The company is developing a new class of molecular diagnostic test device for a range of clinical applications. Founded by an experienced and highly successful leadership team, Sense has ambitious plans to grow from its strong foundations and become a leader in the field. The company has significant backing from leading venture capitalist investors and is currently industrialising its first commercial products.

Role
This is a strategic leadership role to oversee the formal clinical development of the company’s first IVD products for the US market. The Head of Clinical and Regulatory will work closely with the CEO and CDO to develop the clinical development plans for the Company’s products and to establish and manage the resources to ensure their successful implementation. This is a full-time role to be based at either of the Company’s UK sites, and with some requirement to travel to the USA.

Key Responsibilities
• Provide regulatory and clinical input to the development plans for the company’s products
• Ensure the successful delivery of the prospective clinical trials of the company’s point-of-care tests as suitable to achieve regulatory approval in the US market
• Oversee and manage the company’s CROs to ensure efficient and timely delivery of clinical trials
• Lead the preparation of regulatory submissions, e.g. 510(k) applications, engaging as appropriate with internal and external stakeholders
• Act as the company’s key representative to the FDA and attend relevant meetings, such as pre-submission meetings
• Maintain up to date knowledge of relevant regulations, keeping abreast of recent changes
• Work closely with the quality and regulatory manager to help define the company’s quality procedures in line with both ISO 13485 and 21 CFR part 820
• Provide inputs to key technical documents including product specifications, verification and validation plans etc
• Provide regulatory guidance to the company’s design and development teams

As a member of a small leadership team this role would have substantial impact on the company’s overall prospects and if successful this role would grow with the company as its ambitious plans to build a catalogue of molecular diagnostic products is realised.

Ideal Candidate
Candidates for this role must have significant experience in the development of IVD products for the US market, ideally in the field of molecular diagnostics. Experience of point-of-care tests and CLIA waiver regulations would be an advantage although not essential. Candidates should be familiar with all relevant regulations for US and European markets and comfortable researching and becoming expert in any associated areas they do not already have in depth knowledge of. The candidate will be highly proactive, organised and comfortable taking on the responsibility of delivering the company’s ambitious development goals. The preferred candidate will be driven by achieving success and excited by the prospect of building a company with potential to transform healthcare.

Personal Attributes
The candidate should ideally have the following personal attributes:
• Highly organised
• Motivated to make a difference
• Calm under pressure
• High standard of written English and communication skills
• Able to get on with and influence people both internally and externally to achieve objectives
• Excellent attention to detail
• Flexibility to adapt to a fast-moving environment
• Pragmatic team member and flexibility to work within the dynamics of a cross-functional team
• Excellent communication skills